Hypertonic Saline Inhalation in Acute Bronchiolitis

Acute Bronchiolitis Clinical Trial

Official title:

A Prospective Study on the Use of Hypertonic Saline Inhalation in Acute Bronchiolitis in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03880903
• Other study ID #: HS
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 20, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: mohamed El Tellawy, professor
• Phone: 00201003486595
• Email: mohamed.mohamed51[@]med.au.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute bronchiolitis is a viral infection that occurs in children most commonly in the first 2 years of life and is characterized by respiratory symptoms, resulting in wheezing and/or crackles upon auscultation. It is usually a self limiting illness. However, this condition may be associated with several severe complications, such as apnea,respiratory failure, or secondary bacterial infection

Description:

Acute bronchiolitis is a viral infection that occurs in children most commonly in the first 2 years of life and is characterized by respiratory symptoms, resulting in wheezing and/or crackles upon auscultation. It is usually a self limiting illness. However, this condition may be associated with several severe complications, such as apnea,respiratory failure, or secondary bacterial infection. Bronchiolitis is a significant cause of respiratory disease worldwide. according to the World Health Organization bullet in, an estimated 150 million new cases occur annually; 11-20 million (7-13%) of these cases are severe enough to require hospital admission. Worldwide, 95% of all cases occur in developing countries. Typically, initial clinical manifestations include upper respiratory tract symptoms such as cough, nasal congestion, and low-grade fever lasting 1 to 3 days, followed by expiratory wheezing, nasal flaring, fine crackles, oxygen saturation on presentation<94%, tachypnea, increased work of breathing, use of accessory muscles, and retractions in some patients. The need for hospitalization depends on the presence of respiratory symptoms (degree of retractions, increased respiratory effort, decreased oxygen saturation), cyanosis, restlessness or lethargy, and underlying disease states, including apnea. Since no definitive antiviral therapy exists for most causes of bronchiolitis, management of these infants should be directed toward symptomatic relief and maintenance of hydration and oxygenation. One medication that has demonstrated promising results in the management of acute bronchiolitis is nebulized hypertonic saline , Its hyperosmolarity helps to absorb water from the mucosal and submucosal space, thereby increasing mucociliary function by clearing fluids accumulated in the airway and mucus plugs in the lungs. Hypertonic saline can also induce cough to help enhance mucus clearance. The American Academy Of Pediatrics guidelines recommend administration of hypertonic saline in hospitalized bronchiolitis patients. The most common dosage studied is hypertonic saline 3% 4 mL per dose inhaled by nebulizer every 4 to 6 hours, which may take ≥24 hours to work and is typically continued while the child is hospitalized.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: September 20, 2021
• Est. primary completion date: March 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

Inclusion Criteria:

• infants less than 24 months of age with adiagnosis of acute bronchiolitis

Exclusion Criteria:

• other infants and children above 24 months of age

• patients with other diseases than acute bronchiolitis

Related Conditions & MeSH terms

• Acute Bronchiolitis
• Bronchiolitis

Intervention

Drug:
• normal saline and salbutamol
patients will recieve treatment with nebulized salbutamol and normal saline every 4 to 6 in hours
• hypertonic saline and salbutamol
patients will recieve treatment with nebulized salbutamol and hypertonic saline 3% in adose of 4ml every 4 to 6 hours
• Hypertonic saline
patients will recieve treatment with nebulized hypertonic saline 3% in adose of 4ml every 4 to 6 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Rudan I, Tomaskovic L, Boschi-Pinto C, Campbell H; WHO Child Health Epidemiology Reference Group. Global estimate of the incidence of clinical pneumonia among children under five years of age. Bull World Health Organ. 2004 Dec;82(12):895-903. Epub 2005 Ja — View Citation

Smyth RL, Openshaw PJ. Bronchiolitis. Lancet. 2006 Jul 22;368(9532):312-22. Review. — View Citation

Teshome G, Gattu R, Brown R. Acute bronchiolitis. Pediatr Clin North Am. 2013 Oct;60(5):1019-34. doi: 10.1016/j.pcl.2013.06.005. Epub 2013 Jul 24. Review. — View Citation

Zorc JJ, Hall CB. Bronchiolitis: recent evidence on diagnosis and management. Pediatrics. 2010 Feb;125(2):342-9. doi: 10.1542/peds.2009-2092. Epub 2010 Jan 25. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital length of stay	time taken to discharge or ready to be discharged	24 hours